Abstract
A simple, economic, accurate stability indicating RP-HPLC method was developed and validated for the estimation of tenofovir disoproxil fumarate in tablet dosage form. The method was carried out using HYPERSIL BDS C18 (150 x 4.6 mm, 5µm column). The detection was carried out at the wavelength of 254nm. The elution was achieved isocratically with a mobile phase comprising a mixture of potassium dihydrogen phosphate buffer pH 6.5 and Acetonitrile in the ration of 60:40 (%v/v). The flow rate was 1.0 ml/min. The procedure was validated as per ICH rules for specificity, accuracy, linearity, precision, ruggedness, LOD, LOQ and robustness. Under different prescribed stress conditions (acid, base, peroxide, thermal, photolytic and humidity) following the ICH guidelines indicating the method is selective and specific. The linearity range was 25% to 150%, with the correlation coefficient of 0.9990. The percentage recovery for tenofovir disoproxil fumarate was found to be 99.49-100.05%. Limit of detection and limit of quantification was found to be 0.1382µg/ml and 0.4188µg/ml respectively. The assay of tablet dosage form was found to be 99.48%. The developed method was successfully applied to estimate the amount of Tenofovir disoproxil fumarate in tablet formulations.
